BEUDAMED
    FDA Adverse Event Injury Summary report: N

    180 T565 RH

    MDR report key: 12051558 · Received June 23, 2021

    Report

    Report Number
    3003124453-2021-00015
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    March 13, 2020
    Report Date
    June 23, 2021
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACORN DOES NOT HAVE ANY RECORD THAT THE USER REPORTING THE (B)(6) 2020 INCIDENT PRIOR TO 5/24/2021. THE STAIRLIFT WAS NOT USED AS INTENDED. THE STAIRLIFT IS INTENDED TO TAKE USERS THE LENGTH OF THE STAIRS WITHOUT INTERRUPTION. WHEN THE USER DECIDED TO TURN OFF THE LIGHT SWITCH, MID TRAVEL, THE USER STOPPED USING THE STAIRLIFT FOR ITS INTENDED USE. ADDITIONALLY, THE USER WAS NOT WEARING THE SEATBELT, WHICH COULD HAVE KEEP HER FROM FALLING OUT OF THE SEAT WHEN SHE ATTEMPTED TO TURN OFF THE LIGHT. ACORN SENT AN OUT OF SPECIFICATION LETTER REMINDING THE USER TO SIT BACK IN THE SEAT AND WEAR SEATBELT WHEN RIDING THE STAIRLIFT.

    Description of Event or Problem · 1

    ON 5/24/2021, THE USER CONTACTED ACORN STAIRLIFTS, INC. (ACORN) FOR AN ANNUAL INSPECTION AND REPORTED THAT ON (B)(6) 2020 SHE FELL OUT OF THE STAIRLIFT. WHILE RIDING UP STAIRS, THE USER NOTICED SHE NEEDED TO TURN OFF THE DOWNSTAIRS LIGHTS. THE USER ATTEMPTED TO TURN OFF THE LIGHT SWITCH ON THE OPPOSITE WALL WHILE THE STAIRLIFT WAS MOVING AND FELL OUT OF THE CHAIR. THE USER WAS TAKEN TO THE ER AND WAS DIAGNOSED WITH A BROKEN LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949244 180 T565 RH POWER STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization